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Unichem Laboratories receives USFDA ANDA approval for Tramadol Hydrochloride Tablets

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Unichem Laboratories has received ANDA approval from US FDA for Unichem's Tramadol Hydrochloride Tablets USP, 50 mg. to market a generic version of Ultram Tablets, 50 mg, of Janssen Pharmaceuticals, Inc. which are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

The Product will be commercialized from Unichem's Ghaziabad plant.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Tue, August 13 2019. 10:14 IST
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